Overview

An Effectiveness and Safety Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain.

Status:
Completed
Trial end date:
2004-02-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the onset of pain relief from a single dose of acetaminophen and ibuprofen in subjects experiencing postoperative dental pain following the surgical extraction of at least three molars.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Treatments:
Acetaminophen
Ibuprofen
Criteria
Inclusion Criteria:

- Indicates moderate to severe pain following the extraction of at least three molars
(including at least one partial or complete bony mandibular third molar impaction)

- weighs at least 100 pounds and has a Body Mass Index (BMI) between 18 and 28

- Not taking any medications for anxiety, depression or schizophrenia

- if female, not pregnant or breastfeeding

Exclusion Criteria:

- Used ibuprofen or acetaminophen Used ibuprofen or acetaminophen within 12 hours
preceding surgery or any other pain relievers or anti-inflammatory drugs within 24
hours preceding surgery

- have any gastrointestinal disease that would interfere with the absorption and
excretion of study medications

- unable to swallow the study medication whole

- have any significant medical condition

- have a history of adverse reactions to acetaminophen, ibuprofen or any anesthetic
agent used in the extraction